510(k) Report

510(k) · Cleared

Cleared

Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

K250298510(k) TraditionalCleared Oct 8, 2025250-day reviewClass II21 CFR 884.4340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Clinical Innovations, LLC · HDB Extractor, Vacuum, Fetal

Cleared on Oct 8, 2025 as substantially equivalent to K981260 (Clinical Innovations, Inc., 1998) after a 250-day review. Its family tree reaches back 3 generations to 1989.

Decided
Oct 8, 2025
Review
250 days
Class
Class II
Product code
HDB
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K890307 (1989). 7 ancestors in all, the oldest K881967 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestors1994: 1 other ancestor1988: 1 other ancestorK890307 · Mityvac M Style Vacuum Extractor, Disposable · Neward Enterprises, Inc. · 1989K970170 · Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve · Richard G. Lindsay · 1997K981260 · Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M · Clinical Innovations, Inc. · 1998 · recalled1990200020102020
Other ancestors, by generation 2 generations back: 4 other ancestors K981260 · Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M · Clinical Innovations, Inc. · 1998 · recalledK970170 · Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve · Richard G. Lindsay · 1997K890307 · Mityvac M Style Vacuum Extractor, Disposable · Neward Enterprises, Inc. · 19890
  1. Root · 3 generations backK890307 Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc. · 1989
  2. 2 generations backK970170 Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveRichard G. Lindsay · 1997
  3. 1 generation backK981260 Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom…Clinical Innovations, Inc. · 1998 · Recalled
  4. This deviceK250298 Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi®…Clinical Innovations, LLC · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K890307Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc.1989—
−2K970170Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveRichard G. Lindsay1997—
−1K981260Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with…Clinical Innovations, Inc.19982
0 (this device)K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete…Clinical Innovations, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199410
199520
FIG. 1 — Lineage of K250298, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K981260Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump…
Summary page 5
…Regulation Number: 884.4340 Product Code: HDB (Extractor, Vacuum, Fetal) Regulatory Class: II III. PREDICATE DEVICE Kiwi Complete Vacuum Delivery System (K981260). The predicate device has not been subject to a design-related recall.…
Clinical Innovations, Inc.19982

Also cleared against K981260: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 1 other device also cites its predicate K981260.

How does its category compare?

All HDB devices

HDB Extractor, Vacuum, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · HDB

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HDB

Too few HDB 510(k)s in any year since 2007 to give a median.

Recalls per year · HDB

3in 2008

2008: 32026 (partial year): 1
2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HDB

17in 2025

2007: 252008: 352009: 122010: 132011: 82012: 92013: 72014: 112015: 132016: 152017: 162018: 252019: 312020: 242021: 212022: 122023: 232024: 242025: 17
2007high 35 (2008) · low 7 (2013)2025

MAUDE reports naming product code HDB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—025
20080—335
20090—012
20100—013
20110—08
20120—09
20130—07
20140—011
20150—013
20160—015
20170—016
20180—025
20190—031
20200—024
20210—021
20220—012
20230—023
20240—024
20251—017
20260—1—

What is it indicated for?

The Kiwi Complete Vacuum Delivery System (Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)) is indicated for use in the following conditions:

• Prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate

• Presumed fetal jeopardy that is not considered to be severe

• Elective shortening of the second stage for selected maternal or fetal conditions

Indications for use as stated in the FDA summary.

Also cleared against K981260

1 other device cites the same predicate.

  • K043614Vaculink, Model VCL 3000Medevco, Inc. · 2005

More from Clinical Innovations, LLC

9 FDA decisions under this applicant name. See the company

  • K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC · 2025
  • K223900babyLance Safety Heelstick (BLM, BLN, BLP)Clinical Innovations, LLC · 2023
  • K153591ebb Complete Tamponade SystemClinical Innovations, LLC · 2016
  • K150573ebb Complete Tamponade SystemClinical Innovations, LLC · 20151 recall
  • K140163Koala TocoClinical Innovations, LLC · 2014

Recent decisions in HDB

The HDB category page

  • K041579Medela Single Use Silc Cup, Model 077.0791Medela AG · 2005
  • K043614Vaculink, Model VCL 3000Medevco, Inc. · 2005
  • K021193Fortune Silicone Vacuum Suction, Model #1300Fortune Medical Instrument Corp. · 2003
  • K020447Mityvac Merlin, Model 10027Prism Enterprises, Inc. · 2002
  • K013460Swift Low Profile Cup (Pro Cup)Swift Delivery Products · 2002

https://510kreport.com/device/K250298 · printed Nov 4, 2026

Cite this page

510(k) Report. “K250298: Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250298

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026